The Cinnamon Trial

Nestlé Health Science has presented evidence from the CINNAMON trial showing that a whey-based extensively hydrolysed formula (SMA® Althéra®) containing two Human Milk Oligosaccharides (HMOs; 2'FL and LnNT) supports normal growth and is well tolerated by infants with Cows' Milk Allergy (CMA)

12 November 2019, Epalinges, Switzerland.

Nestlé Health Science has presented new evidence showing that adding two Human Milk Oligosaccharides (HMO) to the whey-based extensively hydrolysed formula, SMA® Althéra®, supports normal growth and is well tolerated by infants with cows’ milk allergy (CMA).

The CINNAMON trial assessed if the whey-based EHF, SMA® Althéra®, supplemented with two HMO and a reduced protein content of 2.20g/100kcal, supports normal growth and is well tolerated in infants with CMA, in comparison to SMA® Althéra® without HMO and a higher protein content (2.47g/100kcal).

The primary outcome of the study was met, confirming that there were no significant differences in daily weight gain or other growth parameters between the two groups. The test formula was well tolerated and adverse event rates were similar between test and control groups. Furthermore, the analysis of the per per-protocol cohort suggests a reduced risk of respiratory and ear infections, as well as lower antibiotic and antipyretic use in the test group, however sample size limitations did not allow firm statistical conclusions on these secondary outcomes.

Data presented at the bi-annual Pediatric Allergy & Asthma Meeting (PAAM) in Florence, Italy on October 19 2019 is based on the CINNAMON study, the second trial testing the extensively hydrolysed formula (EHF), SMA® Althéra®, supplemented with the two HMO, 2’fucosyl-lactose (2’FL) and lacto-N-neotetraose (LNnT). This is a specific HMO blend developed by Nestlé. Learn more about the CINNAMON study here. The first trial (IVORY) was published earlier this year and confirmed the safety and hypoallergenicity of this specific HMO blend according to the criteria set by the American Academy of Pediatrics (AAP).1 Learn more about the IVORY trial here.

HMO are non-digestible carbohydrates which make up the third largest solid component in breast milk, after lactose and lipids. While protective benefits of HMO have been investigated for several decades, the production of structurally-identical HMO has only recently become technically feasible.

A high protein intake during early and late infancy is associated with rapid weight gain and an increased risk of subsequent overweight and obesity later in life.2 Nestlé Health Science has therefore lowered the protein content in Althéra. The potential benefits of the lowered protein content include the prevention of excess weight gain and metabolic dysregulation, leading to reduced risk for subsequent overweight, obesity, and related comorbidities.2,3

CMA impacts up to 3% of infants and is associated with digestive, skin, respiratory and other symptoms. Breastfeeding is the best way to feed an infant with CMA. However, when an infant cannot be breast-fed, because CMA is an immune-mediated disease, they may benefit from the immune-modulating properties of HMO.4

“HMO are critical to the support of an infant’s immune system,” said Dr. Ralf Heine, pediatric allergist and clinical development lead at Nestlé Health Science. “HMO support the establishment of beneficial bacteria in the gut, where they modulate the immune system. They eliminate some pathogens through a decoy effect, while also strengthening the gut barrier and guiding the maturation of the immune system. Adding HMO to infant formulas has been shown to provide additional health benefits.5

Nestlé Health Science is committed to HMO research in infants with CMA. SMA® Althéra® and SMA® Alfamino® with 2’FL and LNnT will be the only products for the management of CMA with two of the most significant HMOs.1

IMPORTANT NOTICE: Mothers should be encouraged to continue breastfeeding even when their infants have cow’s milk protein allergy. This usually requires qualified dietary counseling to completely exclude all sources of cow’s milk protein from the mothers’ diet. If a decision to use a special formula intended for infants is taken, it is important to give instructions on correct preparation methods, emphasizing that unboiled water, unsterilized bottles, or incorrect dilution can all lead to illness. Formula for special medical purposes intended for infants must be used under medical supervision.

1. Nowak-Wegrzyn A. et al. Nutrients 2019,11,1447.
2. Koletzko B, et al. Ann Nutr Metab 2017;70:161-169.
3. Singhal A et al. Lancet. 2004; 363: 1642–5.
4. Høst A. Ann Allergy Asthma Immunol 2002;89(Sup1):33-7.
5. Puccio G, et al. J Pediatr Gastroenterol Nutr 2017;64(4):624-631.

*HMOs: structurally identical Human Milk Oligosaccharides, not sourced from breast milk.